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New treatment option for Primary Mediastinal Large B-cell Lymphoma (PMBCL)
Official title Pembro Plus CAR T-cell Therapy in R/R in PMBCL
ClinicalTrials.gov ID: NCT05934448
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for primary mediastinal large b-cell lymphoma (pmbcl).
Also referred to as Keytruda.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This research study is evaluating the combination of drugs, pembrolizumab with chimeric antigen receptor (CAR) T-cell therapy, as a possible treatment for primary mediastinal B-cell lymphoma that has recurred after prior treatment. The names of the study drugs involved in this study are: \- Pembrolizumab Standard treatment will include: CAR T-cell therapy (either axicabtagene-ciloleucel or lisocabtagene maraleucel) Cyclophosphamide Fludarabine
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed diagnosis of PMBCL, EBV+ DLBCL or THRLBCL at one of the participating institutions.
- Availability of archival or freshly collected tumor tissue before study enrollment. If archival tissue is unavailable or is determined to be...
- Eligible for standard of care CAR T-cell therapy with progression after at least two prior lines of therapy OR refractory to initial...
- ECOG Performance Status of 0 or 1.
- Left ventricular ejection fraction (LVEF) ≥ 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO).
You likely can't join if
- Patients in urgent need of cytoreductive therapy.
- Participants who are receiving any other investigational agents.
- History of other malignancies, except:
- Malignancy treated medically or surgically with curative intent and with no known active disease present for ≥2 years before study registration
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease.
See the full eligibility criteria
Who can join
- Histologically confirmed diagnosis of PMBCL, EBV+ DLBCL or THRLBCL at one of the participating institutions.
- Availability of archival or freshly collected tumor tissue before study enrollment. If archival tissue is unavailable or is determined to be inadequate, tumor tissue must be obtained from a biopsy performed at...
- Eligible for standard of care CAR T-cell therapy with progression after at least two prior lines of therapy OR refractory to initial chemoimmunotherapy OR relapse within 12 months of front-line chemoimmunotherapy OR one...
- ECOG Performance Status of 0 or 1.
- Left ventricular ejection fraction (LVEF) ≥ 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO).
- Adequate hematologic function (unless due to underlying disease, as established for example, by extensive bone marrow involvement or due to hypersplenism secondary to the involvement of the spleen by lymphoma per the...
- ANC ≥ 1,000/μL
- Hemoglobin ≥ 8 g/dL
- Platelet count ≥ 50,000/μL
- Participants must have adequate organ as defined below:
- Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \>1.5 × ULN
- AST(SGOT)/ALT(SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver involvement)
- Adequate renal function defined by serum creatinine ≤1.5 x ULN or creatinine clearance (by Cockcroft-Gault) ≥ 40 ml/min for patients with serum creatinine \>1.5 x ULN
- At least one bi-dimensionally FDG-avid measurable lymphoma lesion on PET/CT scan, defined as ≥ 1.5 cm in its longest dimension on CT scan, or ≥ 1 cm if extranodal (and measurable).
- Women of childbearing potential (WOCBP) and men must agree to use effective contraception when sexually active. This applies for the time period between signing of the informed consent form and 6 months for WOCBP and...
- Age ≥18 years.
- Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- Patients in urgent need of cytoreductive therapy.
- Participants who are receiving any other investigational agents.
- History of other malignancies, except:
- Malignancy treated medically or surgically with curative intent and with no known active disease present for ≥2 years before study registration
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease.
- Localized prostate cancer and low-risk prostate cancer on active surveillance
- In the opinion of the treating investigator, there is limited potential to interfere with the safety or how well it works of the investigational regimen. Such exceptions must be approved by the Sponsor-Investigator.
- Has received a live vaccine within 30 days prior to study registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever...
- Less than 6 months of response to prior PD-L1 inhibitor or PD-1 inhibitor or grade 3 or higher immune-related adverse events.
- Prior treatment with CAR T-cell therapy.
- Lactating or pregnant. Women of childbearing potential (WOCBP) must have a negative pregnancy test (urine or serum) at screening. WOCBP will require a negative pregnancy test within 72 hours prior to starting treatment...
- Known active lymphomatous involvement of the central nervous system. History of prior CNS involvement is allowed.
- Recent infection requiring intravenous antibiotics that was completed ≤7 days before the first dose of study drug, or any uncontrolled active systemic infection.
- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus infection.
- History of Human immunodeficiency virus (HIV)-infection.
- Has received prior radiotherapy within 2 weeks of study registration. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
- Has received prior systemic anti-cancer therapy within 2 weeks or investigational agents within 4 weeks.
- Significant liver disease, such as hepatitis (viral or non-viral) or cirrhosis
- Prior macrophage activation syndrome (MAS) or hemophagocytic lymphohistiocytosis (HLH)
- Uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome...
- Known history of central nervous system or neurologic disease including stroke or intracranial hemorrhage within 3 months prior to enrollment or seizure disorder. Prior CNS involvement with lymphoma is allowed if...
- Prior solid organ or allogeneic stem cell transplant or within 6 weeks of autologous stem cell transplant.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
- Is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to study registration. Replacement therapy...
- Active pneumonitis or interstitial lung disease.
- Severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or...
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Has not met requirements for standard of care CAR-T therapy
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.